Cleared Special

K103000 - SMART READ BIOLOGICAL TEST PACK

K103000 is an FDA 510(k) clearance for SMART READ BIOLOGICAL TEST PACK, manufactured by Steritec Products Mfg Co, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Special 510(k) pathway after a 126-day FDA review.

K103000 · Steritec Products Mfg Co, Inc. · General Hospital
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Feb 2011
Decision
126d
Days
Class 2
Risk

K103000 is an FDA 510(k) clearance for the SMART READ BIOLOGICAL TEST PACK. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products Mfg Co, Inc. (Engelwood, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103000

510(k) Number K103000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2010
Decision Date February 11, 2011
Days to Decision 126 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Modification to existing cleared device.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 264
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K103000.
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K102363 · Spsmedical Supply Corp. · Jan 2011
DANA EMULATING INDICATOR
K100891 · Dana Products, Inc. · Jan 2011
K103000 · SMART READ BIOLOGICAL TEST PACK
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